IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157768
Recruitment Status : Unknown
Verified August 2008 by Medtronic Bakken Research Center.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : August 5, 2008
Information provided by:
Medtronic Bakken Research Center

Brief Summary:
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Implantable cardioverter defibrillator Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)
Study Start Date : June 1999
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different.

Secondary Outcome Measures :
  1. Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
  2. Device-related complications, Hospitalizations, Quality of life

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • acute myocardial infarction (5-31 days)
  • fulfill requirement I and/or II :

    • I first ECG heart rate >= 90 bpm (within day 1-2 post MI) and LVEF <= 40 % (within day 5-31 post-MI)
    • II >= 1 episode of non-sustained ventricular tachycardia >= 150 bpm (on Holter, within 5-31 days post-MI)

Exclusion Criteria:

  • Patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later
  • Patients with therapy refractory heart failure (NYHA IV)
  • Myocardial infarction older than 31 days
  • First-ECG not available or was recorded more than 48 h after the symptom onset.
  • Patients with indication for CABG operation before inclusion
  • Patients with cerebral organic psycho syndrome
  • Secondary diseases which clearly limit life expectancy
  • Patient with right sided artificial heart valve
  • Patients with poor compliance
  • Patients who are participating in another study
  • Unstable clinical condition
  • Pregnancy
  • No consent from patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157768

Medtronic Bakken Research Center B.V.
Maastricht, Netherlands
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: D. Andresen, Prof. Klinikum am Urban, Berlin, Germany
Principal Investigator: J. Senges, Prof. Herzzentrum Ludwigshafen, Germany
Principal Investigator: G. Steinbeck, Prof. Klinikum Grosshadern, Munich, Germany

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00157768     History of Changes
Other Study ID Numbers: Medtronic_BRC_CRM_002
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008

Keywords provided by Medtronic Bakken Research Center:
Acute myocardial infarction
Non-sustained ventricular tachycardia
Left ventricular dysfunction
Implantable cardioverter defibrillator

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases